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Conformity Assessment for Medical Equipment

Conformity Assessment for Medical Equipment

Are you getting ready for a medical device audit at your company? 

Accredium Certifications  provides the knowledge and experience necessary to conduct a thorough review and evaluation of your medical device against all relevant regulations.

To ensure that our medical devices are safe and effective, we conduct audits and quality checks in accordance with International Medical Device Regulators Forum best practises (IMDRF)

Australia, Brazil, Health Canada, Japan, and the United States are just some of the countries whose requirements have been incorporated into this programme.


Professional Auditing of Medical Equipment

Accounting for Corrective Actions

Assessments Prior to Approval (PAI)

Global Accreditation and Certification

Achieving the 510k CE Mark Compliance

Control of Good Manufacturing Practice Audits

Pretend FDA Inspections

Conformity with ISO Standards ISO 9001 ISO 13485 ISO 14971

In-House Examinations

Verification of Online Computer Systems

Verification of Conformity with the MDD/IVDD/AIMDD

Assessments of GMP, GLP, and GCP environments and readiness

Get an in-depth analysis of your products, systems, and manage systems' readiness to meet regulatory requirements, as well as a detailed plan for staying in compliance going forward.

Services for FDA Regulatory Auditing, Registration, and Approval

Obtaining Approvals in Multiple Markets (US 510K, EU CE Mark, Health Canada MDL)

Evaluation of Product Compliance and Submissions Independently

Examining the EU's Technical File

Examinations for Conformity with the CE Mark

Prototyping a New Product

The FDA's Regulations: A Roadmap for Compliance

Medical Equipment Safety Assessment Program Audit

Seeking to fulfil MDSAP compliance requirements. Consulting is a service offered by Core Compliance.

Regulatory audit services from Accredium certification s team of FDA-experienced auditors help guarantee that your quality system does more than just satisfy the agency's minimum standards. It ensures that your quality system is giving you the data you need to manage product quality, employee performance, and production efficiency, all of which are crucial to the success of your business.

A few examples of audits are:

Closure of Corrective Action Plans

Examinations for Conformity with the CE Mark

Processing Complaints

Tests for noncompliance and discrepancy studies

Aid in Engineering for Compliance

Audits, evaluations, and fixes for non-compliant computer systems according to Part 11

Methods for Complete Cleanup

Procedures for Conducting Audits and Assessing Compliance and Developing Corrective Action Plans

The Food and Drug Administration conducts simulated GMP, GLP, and GCP inspections, as well as assessments of facility readiness.

Audits for Good Manufacturing Practices

Certified to International Standards Organization (ISO) Requirements ISO 9001/ISO 134

Audits of 21 CFR Part 820 Medical Devices (QSR and QSIT audits)

Verification of Conformity with the MDD/IVDD/AIMDD

Simulation of Good Manufacturing Practice inspections by the FDA

Preapproval Inspection Simulation (PAI)

Registration and Approval in Multiple Countries

Planning reactions to FDA 483s, citations, and warning letters

FDA Quality System/Good Manufacturing Practice Audits Using Quality Control Inspection Techniques

Regular, in-house inspections

Auditing for Software Verification and Quality Assurance

Strategic Advice on GxP Compliance: GCP, GLP, and GCP

Quality assurance checks on suppliers

Inspecting the Supply Chain

Inspecting the Validity of Something

Protocol for Acceptance of Audit Reports

The approval and registration processes are audited by Core Compliance to guarantee compliance. We aid organisations of all stripes in determining whether or not their products and systems are in accordance with regulatory standards, from initial product development through Multi-Country Registration and Approvals. Companies can hire our regulatory consultants on an as-needed basis or keep them on retainer for a predetermined number of hours every month, saving themselves the cost of a full-time employee.

Consultations and services in India pertaining to the implementation of the SEDEX Audit Complinace